Additional OC tasks include:
- Monitoring inspections and timeframes for Prescription Drug User Fee Act (PDUFA) deadlines
- Providing technical assistance for pre-approval inspections
- Conducting pre-inspection briefing for applications that have been marked for extra background information prior to inspection
- Reviewing domestic pre-approval inspection reports and making recommendations for pending applications
Lesson status: Incomplete (0% done)
Topic: page 2 of 3 (Lesson: page 7 of 35)